Why it was recalled
cGMP Deviations: Turbidity discovered in Artificial Tears Ointment during sterility testing. Scope expanded to include other lots and products which potentially share the same root cause.
Product description
Sodium Chloride Ophthalmic Ointment USP, 5%, Sterile, Net Wt 3.5 g (1/8 oz) tube, Mfg by: Akorn, Inc., Lake Forest , IL 600405, NDC 17478-622-35
Lot numbers, UPCs & expiration codes
Lot#: 9J58A, 9J58B, Exp 8/31/2022
Where it was sold
USA nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1496-2022
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Aug 31, 2022
- FDA report date
- Sep 14, 2022
- Quantity
- 48,636 tubes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Akorn, Inc.
Original FDA data
Every field from FDA enforcement report D-1496-2022, exactly as published.
Show all FDA fields
- City
- Gurnee
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 90813
- Address
- 5605 Centerpoint Ct Ste A
- Code information
- Lot#: 9J58A, 9J58B, Exp 8/31/2022
- Postal code
- 60031-5278
- Report date
- Sep 14, 2022
- Product type
- Drugs
- Recall number
- D-1496-2022
- Classification
- Class II
- Recalling firm
- Akorn, Inc.
- Product quantity
- 48,636 tubes
- Termination date
- Jun 18, 2024
- Reason for recall
- cGMP Deviations: Turbidity discovered in Artificial Tears Ointment during sterility testing. Scope expanded to include other lots and products which potentially share the same root cause.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Sodium Chloride Ophthalmic Ointment USP, 5%, Sterile, Net Wt 3.5 g (1/8 oz) tube, Mfg by: Akorn, Inc., Lake Forest , IL 600405, NDC 17478-622-35
- Distribution pattern
- USA nationwide
- Recall initiation date
- Aug 31, 2022
- Initial firm notification
- Letter
- Center classification date
- Sep 6, 2022